Business · 02/07/2013Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Early-Phase Clinical Trials of Cellular and Gene Therapy Products

The Food and Drug Administration (FDA) has made available a draft guidance document to help sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products design early-phase clinical trials of these products.